510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KNQClass II

Dilator, Esophageal

21 CFR 876.5365 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KNQ is the FDA product code for Dilator, Esophageal, a class II device type, regulated under 21 CFR 876.5365. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
KNQ
Device name
Dilator, Esophageal
Regulation
21 CFR 876.5365
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
40
Ingested recalls
21

Clearances, product code KNQ

By decision year
40 clearances under product code KNQ with a decision year between 1981 and 2012, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KNQ by decision year
YearClearances
19811
19832
19842
19852
19861
19882
19892
19902
19932
19944
19951
19961
19972
19981
19992
20002
20021
20042
20051
20063
20093
20121

Applicants with the most clearances

Product code KNQ
Applicants holding the most 510(k) clearances under product code KNQ
ApplicantClearances
Boston Scientific Corporation7
Wilson-Cook Medical Inc.5
Medovations, Inc.3
Cordis US Corp.2
Cordis Europa, N.V.2
Ethicon Endo-Surgery Inc2
Keymed, Inc.2
Primrose Medical, Inc.2
Thomas J. Fogarty, M.D.2
Tri-Med Specialties, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order